On assessing bioequivalence using genomic data with model misspecification.

Journal Article (Journal Article)

This study considers the effect of a nonlinear relationship between pharmacokinetic (PK) and genomic data on bioequivalence assessment using genomic data. A true relationship between PK and genomic data is assumed to be quadratic, but a linear relationship is used instead to assess bioequivalence. Based on this misspecified model, we compare the corresponding power function and sample size for testing average bioequivalence (ABE) to those based on the true model. A numerical study is performed to explore the effect of the misspecification.

Full Text

Duke Authors

Cited Authors

  • Lu, Q; Tse, S-K; Chow, S-C; Yang, J

Published Date

  • July 2009

Published In

Volume / Issue

  • 19 / 4

Start / End Page

  • 571 - 579

PubMed ID

  • 20183426

Electronic International Standard Serial Number (EISSN)

  • 1520-5711

Digital Object Identifier (DOI)

  • 10.1080/10543400902963177


  • eng

Conference Location

  • England